We are seeking an ambitious, highly motivated and experienced Analytical Development (AD) Senior Scientist to be involved in analytical method development, qualification and validation. This is an exciting opportunity for a talented scientist to take a leading role in the development of novel, state-of-the-art analytical methods for exosome-based biotherapeutic products. The CMC AD team also supports, as required, CMC analytical testing, batch release activities and analytical method transfer to cGMP contract manufacturing organisations.
We are looking for an individual who is a self-starter, will thrive in a start-up environment, be able to coach and motivate, be able to innovate and relish the sense of accomplishment each day brings in our exciting company.
This position is based at Evox Therapeutics facility at the Oxford Science Park, Oxford, UK and reports to the Principal Scientist, Analytical Development.
- To develop, optimise and qualify the analytical assays for exosome-based biotherapeutics analysis.
- To provide scientific and technical leadership in analytical method development as well as training and coaching/mentoring junior staff.
- To direct troubleshooting of technical and scientific issues and ensure that developed methods are fit for purpose.
- To produce high quality product and platform specific analytical method documentation, such as SOPs, protocols and reports to support regulatory filings.
- To ensure that all analytical data is in compliance with data integrity principles.
- Work collaboratively with Research, Cell Line Development, Upstream Process Development, Downstream Development, Research Manufacturing and Quality in order to develop and establish new techniques and recommend alternative approaches and potential solutions to analytical development issues.
- Ensure a healthy and safe working environment and compliance to GMO/ACDP requirements.
Education and Qualifications:
- Ph.D or BSc/MSc in Analytical Biochemistry, Biotechnology, Molecular Biology, Biological Sciences or a related field.
A highly motivated and ambitious Scientist with:
- Ability to work independently.
- Good conceptual, analytical thinking, problem solving, and organisational skills.
- Ability to work in a high paced team environment, meet deadlines, and prioritise work from multiple projects.
- Strong interpersonal and communication skills with demonstrated ability to work within a team environment.
- Ability to balance multiple priorities and projects at the same time and be able to change priorities as needed by the business.
Experience & knowledge
- Ph.D with relevant industrial laboratory experience in biologics and/or cell/viral product analytical development or BSc/MSc with 7+ years direct industrial laboratory experience as above.
- Proven industry experience in bioassay development and qualification/validation of analytical methods, including, but not limited to, cell-based assays, flow cytometry, qPCR, SDS PAGE, ELISA, and HPLC.
- Working knowledge of regulatory requirements for analytical testing, such as product specifications, stability testing guidelines, qualification/validation guidelines.
- Applicants with experience in exosome, nanoparticle or viral vector analytics, such as Nano flow cytometry, NTA or similar, would be beneficial
- A working knowledge and practical experience with interpretation of analytical data, good understanding of statistical methods and experience using data analysis software is required.
KEY BEHAVIOURAL ATTRIBUTES – ALL STAFF
People with Purpose – We are innovative and creative in the way we work and deliver. We treat each other with respect and dignity and work collaboratively to learn from each other’s strengths.
Driven to Deliver – We strive to deliver our objectives, and then look for our next challenge. We recognise our achievements and celebrate our successes.
Agile and Accountable – We respond to challenges impacting our progress and find creative and innovative solutions to overcome obstacles. We are brave and not afraid to change our approach to achieve a positive outcome in optimum time.
Candid and Constructive – We communicate with honesty and transparency throughout the team. We value giving and receiving constructive feedback to each other and our partners.